Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary IgA Nephropathy

In brief

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Key facts

Study ID

NCT03643965

Run by

Calliditas Therapeutics AB

People needed

365

Starts

2018-09-05

Expected to finish

2023-07-10

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male patients ≥18 years
• Biopsy-verified IgA nephropathy
• Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
• Urine protein creatinine ratio ≥1 g/24hr
• eGFR ≥35 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
• Willing and able to give informed consent

You may not qualify if…

• Systemic diseases that may cause mesangial IgA deposition.
• Patients who have undergone a kidney transplant.
• Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
• Patients with liver cirrhosis, as assessed by the Investigator.
• Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
• Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
• Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
• Patients with diagnosed malignancy within the past 5 years.

Where it is running

• Univ of Arizona, 1501 N Campbell Ave — Tucson, Arizona, United States
• Stanford University Medical Center, 777 Welch Rd — Palo Alto, California, United States
• Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street — Torrance, California, United States
• University of Colorado Health Science Center, 1200 East 19th Av. — Aurora, Colorado, United States
• Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St. — Westminster, Colorado, United States
• Yale University School of Medicine, 330 Cedar Street — New Haven, Connecticut, United States
• Washington Nephrology Associates-Washington DC, 730 24th Street NW — Washington D.C., District of Columbia, United States
• University of Florida-Gainesville — Gainesville, Florida, United States
• Omega Research Maitland, 7912 Forest City Rd. — Orlando, Florida, United States
• Omega Research Maitland — Orlando, Florida, United States
• Northwestern University the Feinberg School of Medicine, 633 North St. Clair — Chicago, Illinois, United States
• Northshore University Health System, 2650 Ridge Av. — Evanston, Illinois, United States
• University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor — Lexington, Kentucky, United States
• University of Louisville-Nephrology — Louisville, Kentucky, United States
• Kidney Care and Transplant Services of New England, PC, 354 Birnie Av. — Springfield, Massachusetts, United States
• University of Minnesota, 717 Delaware St. SE — Minneapolis, Minnesota, United States
• Clinical Research Consultants, LLC, 3930 Washington St — Kansas City, Missouri, United States
• Queens Hospital Centre — Jamaica, New York, United States
• Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place — New York, New York, United States
• Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av — New York, New York, United States
• Mountain Kidney & Hypertension Assoc, 10 McDowell St — Asheville, North Carolina, United States
• University of North Carolina at Chapel Hill, Clinical & Translational Research Centre — Chapel Hill, North Carolina, United States
• Southeastern Nephrology-Whiteville, 800 Jefferson St — Whiteville, North Carolina, United States
• Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive — Wilmington, North Carolina, United States
• University of Alabama at Birmingham, 1720 2nd Ave South — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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